Nasopharyngeal Cancer
Conditions
Keywords
Dendritic Cells, Dendritic Secretomes
Brief summary
The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.
Detailed description
There are three arms controlled group. First group receives standard medical theraphy (radiotherapy or chemoradiation), second group who receives autologous dendritic cell (Auto-DC), and third group receives the combination of allogenic-dendritic cell-secretomes (Allo-DC Secretome) and continued with autologous dendritic cell (Auto-DC).
Interventions
OTHERPlacebo (Aqua Pro-Injection)
Treatment with Aqua Pro-Injection 2 cc 2 times injection, interval 2 days (via Intramuscular).
BIOLOGICALAuto-DC (Autologous Dendritic Cell as Adjuvant Therapy)
Treatment with Aqua Pro-Injection 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)
BIOLOGICALCombination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)
Treatment with Allo-DC-Secretome 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer * Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST * Did not take traditional medicine in the last 2 months. * Patients can understand the nature of the study and willing to sign informed consent * Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.
Exclusion criteria
* Patients who are pregnant, planning to pregnant, or breastfeeding * Patients assessed to require chemoradiation during this study * Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST * Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis * Patients who have creatinin clearance result \<40 ml/min, bilirubin serum \>1.5x above normal, SGPT-SGOT \>5x above normal * Patients on immunosuppressive medications, such as corticosteroids * Patients who undergo Major thoracic or abdominal operation * Patients on high medical risk condition due to uncontrolled infection * Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV) * Patients who have concurrent congestive heart failure history and other heart disease * Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial * Patients who refuse or did not participate in part or all of the research process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Karnofsky Performance Status | Before therapy | To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. |
Countries
Indonesia
Contacts
STUDY_CHAIRRima Haifa, B.Sc
Prodia Stem Cell Indonesia
Outcome results
None listed